NCT02920476

TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)

Completed Phase 2 Results posted Last updated 23 June 2022

What this trial tests

Phase 2 trial testing TAS-102 in Squamous Cell Lung Carcinoma in 4 participants. Completed in 14 August 2021.

Timeline

19 July 2017

Primary endpoint
3 December 2018

14 August 2021

Quick facts

Lead sponsor	University of Florida
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	19 July 2017
Primary completion	3 December 2018
Estimated completion	14 August 2021
Sites	1 location across United States

Drugs / interventions tested

• TAS-102

Conditions studied

• Squamous Cell Lung Carcinoma — all drugs for Squamous Cell Lung Carcinoma →

Sponsor

University of Florida

Who can join

Adults 18 to 90, any sex, with Squamous Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) Primary · 1 year

To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.

Group	Value	95% CI
Treatment Arm	0

Clinical Benefit Rate Secondary · 1 year

To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when

Group	Value	95% CI
Treatment Arm	0

Overall Survival (OS) Secondary · 1095 days

To determine the overall survival in days

Group	Value	95% CI
Treatment Arm	449.25	165 – 1095

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 3/4 (75%)

Deaths: 4/4

Serious adverse events (3 terms)

Reaction	System	Treatment Arm
Shoulder pain	Musculoskeletal and connective tissue disorders	—
Respiratory infection	Infections and infestations	—
Non-cardiac chest pain	General disorders	—

Other adverse events (18 terms — click to expand)

Reaction	System	Treatment Arm
Vomiting	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Fatigue	General disorders	—
Neutrophil count decreased	Investigations	—
Non-cardiac chest pain	General disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Anorexia	Metabolism and nutrition disorders	—
Bloating	Gastrointestinal disorders	—
Dysgeusia	Nervous system disorders	—
Fever	General disorders	—
Hot flashes	Vascular disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Platelet count decreased	Investigations	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Tremor	Nervous system disorders	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Shoulder pain, Respiratory infection, Non-cardiac chest pain.

Data from ClinicalTrials.gov NCT02920476 adverse events section.

Sponsor's own description

This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.